FDA Medical Device Recalls (openFDA)
Ventus Medical, Inc.: Provent -SR - Sleep Apnea Therapy-SR (standard resistance). Prescription only, Single Use; Packed 30 units per box Manufactured in the USA by Ventus Medical Inc. 1301 Shoreway Road, Suite 425; Belmont, CA 94002 Used in the treatment of obstructive sleep apnea.
- Recall number
- Z-1033-2012
- Recalling firm
- Ventus Medical, Inc.
- Product
- Provent -SR - Sleep Apnea Therapy-SR (standard resistance). Prescription only, Single Use; Packed 30 units per box Manufactured in the USA by Ventus Medical Inc. 1301 Shoreway Road, Suite 425; Belmont, CA 94002 Used in the treatment of obstructive sleep apnea.
- Status
- Terminated
- Initiated
- 2012-02-03
- Posted
- 2012-02-15
- Terminated
- 2012-02-15
- Reason
- A discrepancy was found during inspection of a returned unit that the lot number and SKU on cartoon did not match.
- Root cause
- Labeling mix-ups
- Action
- Ventus Medical sent a Urgent Medical Device Correction Letter dated February 3, 2012, to all affected customers. The letter identified the problem, the product and the action needed to be taken by the customer. There is no health hazard associated with the affected devices or with the continued use of the affected devices. Ventus Medical wanted Customers to be aware of the problem so they can respond to patients if inquiries are received. A sample letter to patients was also provided, should physicians choose to provide it to patients. Questions may be directed to Ventus Medical Territory Business Manager at 650-632-4199.
- Quantity
- 288 units
- Distribution
- Nationwide Distribution including the states of OH, TX, IL, OR, CA, FL and NY.
- Lot, serial or model codes
- Catalog number MRS0227; Lot number: 14261182.
- 510(k) numbers
- ["K090398"]
- PMA numbers
- not on file
- Product code
- OHP
- Firm FEI
- 3007038487
- Firm city
- Belmont
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28